Genetic Future

David Clark at Genomics Law Report has a thorough dissection of the recent and highly restrictive laws passed in Germany governing access to genetic testing. You should read the whole thing to get a sense of what happens when governments grab the wrong end of the regulation stick, but here’s the crucial paragraph:

The German Act […] adopts an extremely protective, even fearful, view of genetic information as something so dangerous and private that the generation and disclosure of genomic data must be mediated solely through specially trained physicians, accompanied by psychological and social counseling, and subject to destruction of the data at any time upon the request of the subject individual. In addition to tightly regulating the doctor/patient relationship, the Act appears intended to outlaw (or at least highly restrict) DTC genetic testing services. One of the laudable purposes of the act, “to protect human dignity and to ensure the individual right to self-determination via sufficient information,” is belied by provisions of the Act that restrict the ability of individuals to access their own genetic information directly.

Why is Germany leading the world in terms of paternalistic, regressive legislation against genetic testing? No doubt there are multiple reasons, but it’s clear that this regulation is driven in part by a desire to steer well clear of anything that might stir up memories of eugenics and medical experimentation on unwilling subjects conducted half a century ago.
Yet those horrors were the result of a government making decisions for people, against their wishes – and as Clark notes, this Act permits the German government to restrict the ability of individuals to make their own decisions about how and when they access their own genetic information.
If the German government wants to demonstrate that it has learnt its lessons from the horrors of its past, it should step back and allow its citizens to make their own informed decisions about their own health, and to gain access to their own genomes without restriction should they wish to do so.

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Comments

  1. #1 Luke
    September 3, 2009

    I don’t think that it really follows that they have failed to learn the lessons of the past. The relevant problem with Nazism was hardly the ‘government making decisions for people against their wishes’, that is far too general: the specific problem was an ideological and popular view that an individual’s genetic makeup determines their value or their right live a normal life.

    If Germany believes that they want to steer as clear as humanly possible from any popular belief in the importance of genetics in society, then saying ‘only under strictly controlled medical-related situations will someone’s genetic information be allowed to play any role in their life’ is a perfectly sensible way of going about it.

    We might disagree that it is a good idea to try and hold back this technology, or disagree that genetic testing has any necessary connection with eugenics, but their over-cautionary stance is hardly an inadvertent wandering towards fascism.

  2. #2 Sigmund
    September 3, 2009

    I tend to regard German attitudes to genetics to be more governed by a sort of technological luddite-ism mixed with political correctness that is generally associated with the green parties across Europe.
    Looking at the results of their actions in certain areas it is sometimes difficult to tell apart modern right wing conservatism and left wing environmentalism/political correctness. For instance the Irish Green Party was instrumental in getting the recent blasphemy law put into law in Ireland.

  3. #3 Davide
    September 3, 2009

    How does it go? The new fascists will be the anti-fascists? Something like that anyway.

  4. #4 Kismet
    September 3, 2009

    Luke, sorry if I am blunt, but you couldn’t be any more mistaken. Germany *is* undeniably wandering towards fascism. You call this madness perfectly sensible?

    Germany has been leading the developed world (or at least Europe) in terms of censorship and oppression for quite some time. “To protect human dignity” – cynical nonsense!

  5. #5 Paul
    September 3, 2009

    I wouldn’t rush to condemn the German Government on this one. Sigmund is right that the attitude of German governments to science, expecially the biological sciences, often tends towards ludditism, usually a result of it’s religious right and the strong green movement, but there’s no doubt that the lingering worry about eugenics still affects decisions there.

    This might be why the restrictions on prenatal genetic testing are so strict…this strikes me as the worst part of the legislation.

    So far as restrictions on direct to consumer genetic testing is concerned I’m not worried by them, it’s well known that many of these tests are pretty flawed and provide a very incomplete view of an individuals genetic predisposition to disease. Interpreting the results of such tests requires a good appreciation both of the specifics of the diseases concerned and the relative risks that particular genetic variations carry. think of how often you’ve seen news reports along the lines “that gene X doubles your chance of getting disease Y”, with of course no mention that it’s from 1 in 1,000 to 2 in 1,000. I’d take some convincing that your average family doctor/GP would have the expertise to understand the results and aadvise/council their patient appropriately. To be honest the idea that members of the public who have had no formal training in medicine or science have unrestricted, unguided access to this information fills me with dread, at best it strikes me as another way for charlatans to make pots of money from the worried well.

    I’d prefer such tests to be undertaken under the supervision of specialists who can offer reliable advice on what the results mean and what if anything the patient should do about them.

    Now if only the German government could adopt such a skeptical approach to all the alt med cranks that the German health system supports!

  6. #6 Sigmund
    September 3, 2009

    “To be honest the idea that members of the public who have had no formal training in medicine or science have unrestricted, unguided access to this information fills me with dread, at best it strikes me as another way for charlatans to make pots of money from the worried well.”
    I think you show a rather paternalistic attitude towards the public.
    For instance I am not a qualified physician so is it right that in Germany I should not have the opportunity to get my genotype analyzed in this way? I happen to have a PhD in molecular genetics and have worked in human genomics for nearly 15 years and have no doubt I know more about genetics than most physicians – or even genetic counsellors who tend to stick to specific diseases.
    OK, I may be an exception to the rule but what about pro-science people who want to educate themselves about their genetics or the deep history of their genes?
    Should we prevent everyone from accessing their information simply to protect the gullible section of the community?

  7. #7 Paul Browne
    September 3, 2009

    Sigmund, I would certainly conside you to be an exception, my own scientific background makes me another such exception. Nevertheless I would be content to have to go through a few more hoops in order to obtain this information if it means that those without the knowledge or training to deal with this information are protected. I don’t think it’s just a case of protecting a small gullible section of the community, there are a lot of life scan type companies out there that make a tidy profit by charging people for testing that the vast majority don’t need and won’t benefit from. They are very good at selling their services, and not just to those that tend to fall for every 419 scam that comes their way.

  8. #8 Sigmund
    September 3, 2009

    There are lots of tests that can be done with people that give them information. Some of them provide real scientific information (genotyping – the snp results across their genome) and some give pseudoscientific information – the usual sort of quack therapies, too numerous to list.
    Obviously there is the potential for misuse in both types of tests – especially if you do not give proper disclaimers about the accuracy and the responsibility on the testee.
    What I wonder is why should the scientific test be the one that is restricted while the worthless and dangerous pseudo-scientific tests are freely available?

  9. #9 Paul
    September 3, 2009

    Oh I agree about the vast amount of pseudoscientific nonsense that is freely available (btw please support http://www.senseaboutscience.org.uk/index.php/site/project/333/), I guess I’m just a bit more sensitive about anything that is likely to bring real science and medicine into disrepute.

  10. #10 Sigmund
    September 3, 2009

    Paul, I think there is certainly an onus on these genomics companies to provide high quality genotyping results and to refrain from claiming specific medical advantages for their products. So long as they work within those guidelines I cannot see a logical reason to restrict them.
    Can you be more specific as to the problems you see arising?

  11. #11 Paul
    September 3, 2009

    Sigmund “So long as they work within those guidelines I cannot see a logical reason to restrict them.”

    Oh right, just like direct to consumer drug sales.

    My worry is not about the quality of the genotyping itself, but the difficulty in interpreting the results. For example a variation might be known to be associated with an increased disease risk, but does it cause it? For most genetic variations we only have a vague idea, if that, of how they affect health. Even if causality is demonstrated there’s the whole problem of understanding relative risk, and the implications steps that might be taken to reduce the risk associated with a particular genetic variation might have on other aspects of an individuals health. That is why I believe that individuals should consult trained doctors before they undergo any screening, whether you’re talking about genetic screening or the health MOTs you see advertised on telly these days.

    Don’t get me wrong, I see personalised genome screening playing a major role in medicine in the coming decades, but it won’t be helped if it is associated with unscrupulous marketing and widespread mis-diagnosis and fear mongering at this early stage.

    Perhaps the German legislation is overly restrictive in only allowing specialist physicians to screen patients, but I do believe that some restriction is a good idea.

    I also believe that the limiting of prenatal genetic screening to treatable medical conditions is potentially far more worrying, as it could harm parents ability to decide whether or not to abort foetuses which may have serious heritable diseases early in pregnancy.

  12. #12 Sigmund
    September 3, 2009

    “Oh right, just like direct to consumer drug sales.”
    I’m afraid you lost me there. What possible connection is a genotyping result to unregulated drug sales? That just sounds like a complete non sequitur.
    Who is currently trained to deal with the amount of data that a single SNP chip provides?
    It’s certainly not general practitioners.
    It’s also not clinical genetic counsellors.
    Who exactly do you trust in this matter?
    Who are the gatekeepers to ones own genomic data?
    I can’t stand the sort of nannying attitude to the public whereby they are treated like children rather than adults who bear responsibility for their own health decisions.

  13. #13 case
    September 3, 2009

    As a German, I have to admit that I’m failing to get worked up about this, after reading the linked post, and also some other articles describing the law.
    Certainly, the restrictions placed upon individuals wanting access to their own genetic informations are ludicrous and overly bureaucratic, and I agree with that part of the criticism.

    On the other hand, David Clark makes some rather strong assertions that are not necessarily borne out by the legislation itself. And they are premature as well, considering that, as he mentions, the law itself “contemplates that it will be fleshed out by future regulatory actions”.

    Secondly, in my understanding of his post, as a contrast to the “paternalistic extreme of the spectrum” exemplified by the German legislation, he appears to be holding up the UK as a better model. There, a “House of Lords Report on Genomic Medicine advises the DTC genetic testing industry to adopt a voluntary code of conduct”.
    Advocating a “voluntary [industry] code of conduct” as an alternative preferable to strong regulation is simply absurd. Obviously, these sorts of agreements are not worth the paper they’re written on.

    As for the political aspect, I’d like to point out that the German Green Party actually voted against this legislation. It was passed by the coalition of the two large center-left (nominally at least) and center-right parties.

  14. #14 anomalous
    September 3, 2009

    Switzerland or Lichtenstein or Poland or Denmark will keep it legal. Deutschlanders can just fahrvernugen over the autobahn to one of these “freedom loving” countries, give them the mouth swab of DNA, pay their $300 Euros or whatever, and get the results over the internet.

    Keine Problem!

    I think we’re passed Kanzler Merkel threatening an invasion to prevent this.

  15. #15 Kismet
    September 3, 2009

    Case, any overly restrictive law that may be enacted in Germany should cause uproar, considering how much bona fide censorship is already going on. Another step in the wrong direction.
    When it comes to bio-legislation I think the UK is one of the few sane countries in most of Europe. Perhaps a good example, if we ignore British libel laws for a second. Just compare British and German or Austrian laws on stem cell research! And now that sort of regulation…

  16. #16 Lucian
    September 4, 2009

    This german law was first designed and heavily discussed back in 2003, following the then common believe that ALL is written in your genes, and as soon as this information comes out, everyone could foretell your health and fate. The law got stuck in process.

    Science has moved on a lot ever since, epigenetics is on the rise. But the political discussion in Germany didn’t cope with this changes. The Act came back on the political agenda, nearly unchanged, still following the old notion. They should have build it up from scratch again, but it’s hard to turn back a political wheel.

    It will take some time until Germany can start to adapt its genomic law again.

  17. #17 Anonymous
    September 4, 2009

    Paul, you wrote:

    “think of how often you’ve seen news reports along the lines “that gene X doubles your chance of getting disease Y”, with of course no mention that it’s from 1 in 1,000 to 2 in 1,000.”

    If you’d actually looked at any of the three major DTC companies’ sample reports, you’d know that they present relative risk along with absolute risk. This implies that people should go to DTC companies–and NOT news reports–for their information about recent genetic discoveries.

    You also wrote:

    “For example a variation might be known to be associated with an increased disease risk, but does it cause it? For most genetic variations we only have a vague idea, if that, of how they affect health.”

    You are correct that many genetic associations are not causal, but this does not mean they should not be used for risk prediction or classification. In fact, many well-known NON-genetic associations are not causal. For example, it has recently been shown in what I am told is a reputable journal that C-reactive protein, which the Gene Sherpa readily points out is part of the clinically validated Reynolds risk score (oops, I just practiced medicine), may not have a causal relationship with coronary heart disease. That doesn’t mean it shouldn’t be used in prediction.

  18. #18 Kismet
    September 5, 2009

    @Lucian
    Were we (as in we, the scienctists) really *that* clueless in 2003? Or was it just the politicians and public at large? I wasn’t even interested in science in 2003, so I can’t tell.

  19. #19 TJ
    September 7, 2009

    The whole controversy here strikes me as a tempest-in-a-teapot. Common genetic variation, of the type that’s represented on the chips used by 23andme and others, doesn’t seem to have much real influence on disease prediction for almost any common disease. As has been pointed out here and elsewhere, the algorithms used to summarize risk can differ only slightly and yet have the result of predicting higher vs lower prediction of disease risk for an individual vs the population average. So in my mind this is purely recreational genomics. So why not let the people have their fun? Are there really large swaths of ignorant people signing up for these tests? And then making drastic changes to their health decisions based on the results? Really?

    Maybe a government decree that these products are unlikely to shed any real light on disease risk should be enough. Caveat emptor, and that’s it.

    There are a few exceptions, such as ApoE and some pharmacogenetics markers that are pretty easy to interpret, by the consumers themselves or by any competent medical authority. These are in the category of truly useful genetic tests, but in these cases the clinical relevance is overwhelming and not even a lazy annotation/description by the DTC companies can get it so wrong that it enters the realm of medical malpractice.

    Just not seeing the problem here.

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